Art Therapy for Symptom Reduction in Acute Schizophrenia - a Randomised Controlled Trial (Kunsttherapie Zur Symptomreduktion Bei Akuter Schizophrenie - Eine Randomisierte Kontrollierte Pilotstudie)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Positive and Negative Syndrome Scale (PANSS-) scores
研究概览
简要总结
Randomised, controlled, single-blinded pilot study to assess the efficacy of psychodynamic art therapy in a sample of hospitalized, (sub)acutely psychotic patients with a diagnosis of schizophrenia compared to a group of patients receiving treatment as usual.
*Main hypothesis: Art therapy has no impact on clinical symptoms and the course of remission compared to TAU.
*Exploratory hypotheses: Art therapy has no influence on quality of life, mentalizing function, self-efficacy and neuroleptic dosage compared to TAU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of schizophrenia according to DSM-IV-TR
- •age 18-64 yrs
- •sufficient German language competency
- •written informed consent
排除标准
- •axis-I mental disorders other than schizophrenia
- •comorbid antisocial personality disorder, relevant substance abuse,
- •relevant severe somatic disease
- •acute suicidal tendencies or aggression
- •incapability to tolerate group settings
结局指标
主要结局
Change in Positive and Negative Syndrome Scale (PANSS-) scores
时间窗: weeks 0, 6, 12
assessment of change of schizophrenic positive, negative and general symptom scores
safety measures
时间窗: weeks 0, 6, 12
number of participants with adverse events
Change in Calgary depression Scale (CDS-) scores
时间窗: weeks 0, 6, 12
assessment of change of depressive symptoms in schizophrenic patients as reflected by CDS-scores
次要结局
未报告次要终点
研究者
Christiane Montag MD
Principal Investigator
Charite University, Berlin, Germany